[pending] Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar
Pending LLM rewrite. Source: FDA_DEVICE Z-0947-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
The recalled product
- Product
- Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
- Manufacturer
- DSAART LLC
- Category
- Medical Device — Devices
Distribution
Distributed in 27 states:
- AR
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- IL
- KY
- MA
- MD
- MI
- MN
- MS
- NE
- NJ
- NY
- OH
- OK
- PA
- PR
- TX
- UT
- VA
- WA
- WI
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